CIRM CLIN2 Clinical Trial Awards
The California Institute for Regenerative Medicine is accepting applications for its CLIN2 Clinical Trial Awards to advance interventional phase 1, phase 2, phase 3, and pivotal clinical trials for eligible stem cell-based and genetic therapies. The current application cycle is open and applications are due October 30, 2026 at 2:00 PM PT. A consultation with the CIRM Clinical Development team is mandatory and must be completed by October 23, 2026 before an application can be submitted.
Funding
Awards support up to four years of work. First-in-human awards are capped at $8 million for for-profit applicants and $12 million for nonprofit applicants. Phase 2 or subsequent phase 1 trials and phase 3 or pivotal trials may request up to $15 million. CIRM anticipates approximately 9 to 16 CLIN2 awards in fiscal year 2026-27, subject to the number and quality of recommended applications.
Eligibility
California and non-California for-profit and nonprofit organizations may apply. The proposed project must be an eligible interventional clinical trial for a stem cell-based or genetic therapy. Therapeutic devices developed under an Investigational Device Exemption are ineligible. The applicant must be the IND sponsor, the Principal Investigator must commit at least 15 percent effort, the project must include an experienced project manager committing at least 50 percent effort and an experienced data project manager, and at least one clinical trial site must be located in California. Applicants must also satisfy readiness requirements, including the applicable FDA IND and protocol requirements, and be prepared to initiate funded work within the required post-approval period.
Co-Funding
Co-funding depends on organization type and trial stage. For-profit applicants, and nonprofit applicants with a for-profit Partner, must provide 30 percent co-funding for first-in-human trials and 50 percent for phase 2 or subsequent and phase 3 or pivotal trials. Nonprofit applicants without a for-profit Partner have no required co-funding for first-in-human or phase 2 or subsequent trials, but phase 3 or pivotal trials require 50 percent co-funding. Manufacturing for a subsequent trial requires 50 percent co-funding when the overall award has a co-funding requirement. Required co-funding documentation must be included by the application deadline, and in-kind support does not satisfy the minimum requirement.
Allowable Scope and Costs
Eligible activities include clinical operations, patient outreach, enrollment and retention, treatment and follow-up under the clinical protocol, data sharing, patient access planning, natural history or qualifying lead-in studies, biomarker and mechanism work, regulatory activities, FDA-required nonclinical studies, strategic planning, and manufacturing for the current trial. Personnel, supplies, travel, equipment, subcontracts, facilities costs, and allowable indirect costs may be budgeted within CIRM rules. Discovery or translational research, costs incurred before approval, duplicate costs covered by another CIRM award, and clinical research conducted under an IDE are not allowable under CLIN2. Proposed subcontracts over $500,000 require a tabulated summary of at least three proposals and detailed selection justification, or a detailed sole-source justification.
Application Components and Submission
Applications are submitted online through the CIRM Grants Management Portal. Applicants must complete the portal eligibility form, identify Key Personnel, list consultants and subcontracts, describe proposed activities, and prepare and justify an activity-based budget. CIRM requires use of the portal-provided templates for the Scientific Proposal, Patient Access Proposal, candidate eligibility information, biosketches, solvency and co-funding information, and other funding-support information. Uploads also include the clinical protocol, FDA correspondence, manufacturing plan, investigator brochure, intellectual property plan, and supporting budget quotes as applicable. Applicants must certify that required institutional approvals such as IRB, SCRO, or IACUC approvals will be in place during the award.
Atlas Analysis
Atlas Opportunity Score: 92/100. This is a large, currently open California healthcare research funding program with clear authoritative eligibility, award, co-funding, application, and deadline requirements.
N9+ Fit Score: 0/100. CLIN2 is limited to eligible stem cell-based and genetic therapy clinical trials, and the Program Announcement expressly excludes clinical research conducted under an Investigational Device Exemption. Atlas should not force a Nonagon N9+ device role into this funding opportunity.
Direct-vendor classification: Not advanced. A legitimate applicant must satisfy IND-sponsor, FDA-readiness, clinical-development, staffing, trial-site, patient-access, and financial requirements. No Dr. Miltie or QC Healthcare direct-submission path should be assumed.
Next Action
Qualified clinical-stage applicants should request the mandatory CIRM Clinical Development consultation immediately, confirm every eligibility and co-funding condition against the current Program Announcement and portal templates, and submit the complete application by October 30, 2026 at 2:00 PM PT.
Official source: California Institute for Regenerative Medicine CLIN2 Awards.